A Phase IB Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Solid Tumors
- Patients ≥18 years old with proven advanced or metastatic solid tumor not amenable to
any clinical improvement by current standard treatments and previously treated with a
non cumulative dose of anthracyclines (<300 mg/sqm) or chemotherapy naïve.
- Life expectancy more than 3 months.
- ECOG performance status 0 - 2.
- Normal cardiac function (left ventricular ejection fraction [LVEF] ≥55%) and absence
of uncontrolled hypertension.
- Absence of any conditions involving hypervolemia and its consequences.
- Adequate baseline bone marrow, hepatic and renal function, defined as follows:
Neutrophils > 1.5 x 10^9/L and platelets >100 x 10^9/L Bilirubin < 1.5 x ULN AST and/or
ALT < 2 x ULN Serum creatinine < 1.5 x ULN
- Patients may have had prior therapy providing the following conditions are met:
- Chemo, radio, hormonal, immuno or anti-vascular therapy: wash-out period of 28
- Surgery: wash-out period of 14 days.
- Patients must give written informed consent to participate in the study.
- Concurrent anticancer therapy
- Patients must not receive any other investigational agents while on study
- Patients with a LVEF <55%
- New York Heart Association class III or IV cardiac disease
- Acute angina
- Patients with myocardial infarction within the last six (6) months
- Patient with significant peripheral vascular disease
- Thrombosis of main portal vein
- Previous signs of severe toxicity doxorubicin related
- Previous signs of cardiotoxicity doxorubicin related
- Patients previously treated with a cumulative dosage of anthracyclines ≥300 mg/m^2
- Clinical signs of CNS involvement
- Patients with active or uncontrolled systemic disease/infections or with serious
illness or medical conditions, which is incompatible with the protocol
- Known hypersensitivity/allergic reaction to human albumin preparations or to any of
- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol
- Pregnancy or lactation. Patients - both males and females - with reproductive
potential (i.e. menopausal for less than 1-year and not surgically sterilized) must
practice effective contraceptive measures throughout the study. Women of
child-bearing potential must provide a negative pregnancy test (serum or urine)
within 14 days prior to registration